At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Evaluation of the Current™ Radio Frequency (RF) Implantable Cardioverter Defibrillator (ICD) Models 2215/1215 and Promote™ RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) Model 3215 Pulse Generators
In Brief
A clinical study evaluating Testing of the autocapture features of the device for Heart Failure and Ventricular Arrythmias. Completed, enrolled 128 participants across 5 sites.
Detailed Summary
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices. These new ICD and CRT-D devices have new features that allow the device to periodically check how much energy is needed to pace a patient's heart and to automatically adjust the amount of energy used to pace the heart.
Study Details
Timeline
Interventions
Patients receiving cardiac resynchronization therapy will have new autocapture features tested on right atrial, right ventricular and left ventricular leads.
Patients with an Implantable Cardioverter Defibrillator will have new autocapture features tested on the right atrial and right ventricular leads.